Preguntas Frecuentes
Is FDA approval useful when entering Colombia, or does the INVIMA process start from scratch?
As experts in INVIMA regulations, our analysis is clear: FDA approval does not provide automatic homologation nor exempt companies from regulatory procedures with INVIMA. However, it is highly valuable and can help streamline or simplify certain parts of the process.
What types of agreements are most commonly used in LATAM (dossier, supply, tech transfer, distribution)?
It depends on the commercial strategy: dossier licensing, licensing and supply agreements , technology transfer, or exclusive/non-exclusive distribution agreements.
Why are eCTD and CTD important?
The Electronic Common Technical Document (eCTD) allows the electronic submission of the Common Technical Document (CTD) from applicants to regulatory authorities such as the FDA or the EMA.
Therefore, if you are applying for the registration of a pharmaceutical, biological, medical device, or veterinary product, the eCTD format will be mandatory for regulatory submissions.
What is a CPP/CLV and in which countries is it required for registration or importation?
A Certificate of Pharmaceutical Product (CPP) or Certificate of Free Sale (CLV) is evidence that a product is authorized or marketed in its country of origin. Many countries require it depending on the registration modality.
These documents are important for the importation and commercialization of products in international trade.
When does bioequivalence (BE) apply and how does it impact licensing costs?
If the market requires bioequivalence for a specific product, the dossier fee usually increases, and the implementation timeline depends on the availability of a valid study.
Bioequivalence is used to indirectly determine whether a generic drug is safe and effective by comparing it to a reference product that has undergone clinical trials. This is especially relevant for biotherapeutic drugs, where interchangeability between products can be challenging.
Bioequivalence not only guarantees clinical interchangeability between generic medicines and their reference products but also represents a strategic tool for the sustainability of healthcare systems and broader access to safe and effective therapies.
